Browse Drug Recalls

1,732 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,732 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 1,732 FDA drug recalls, Class I.

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DateProductReasonClassFirm
Jan 9, 2016 Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules tot... Marketed Without An Approved NDA/ANDA Class I R Thomas Marketing, LLC
Jan 9, 2016 Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 4... Marketed Without An Approved NDA/ANDA Class I R Thomas Marketing, LLC
Jan 9, 2016 Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 caps... Marketed Without An Approved NDA/ANDA Class I R Thomas Marketing, LLC
Jan 9, 2016 Germany Niubian, packaged in BIG BOX (10 small boxes / 24 capsules per box / ... Marketed Without An Approved NDA/ANDA Class I R Thomas Marketing, LLC
Jan 9, 2016 Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 ca... Marketed Without An Approved NDA/ANDA Class I R Thomas Marketing, LLC
Jan 9, 2016 Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 c... Marketed Without An Approved NDA/ANDA Class I R Thomas Marketing, LLC
Jan 9, 2016 Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 ca... Marketed Without An Approved NDA/ANDA Class I R Thomas Marketing, LLC
Jan 9, 2016 African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsul... Marketed Without An Approved NDA/ANDA Class I R Thomas Marketing, LLC
Jan 9, 2016 Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsule... Marketed Without An Approved NDA/ANDA Class I R Thomas Marketing, LLC
Jan 9, 2016 Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 c... Marketed Without An Approved NDA/ANDA Class I R Thomas Marketing, LLC
Jan 5, 2016 Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g T... Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which ... Class I Hospira Inc.
Dec 29, 2015 Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous adm... Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture. Class I Complete Pharmacy and Medical Solutions LLC
Dec 23, 2015 Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for... Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolp... Class I Bee Xtreme
Dec 23, 2015 APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclus... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Nuway Distributors, LLC
Dec 23, 2015 Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured f... Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolp... Class I Bee Xtreme
Dec 23, 2015 La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufac... Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolp... Class I Bee Xtreme
Dec 15, 2015 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx... Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in th... Class I Baxter Healthcare Corp.
Dec 15, 2015 SlimeX-15 Capsules, 15 mg, 30-count bottles, Marketed by: Signature Pharmaceu... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 Asset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC www... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N O... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 Ultimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu ... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 SLIM TRIM U Capsules, 250mg, 60-count bottles, Manufactured for Floyd Nutrition Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 La' Trim Plus Capsules, 350 mg, 60-count bottles, Manufactured for: MWN Heal... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Soluti... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E.... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bu... Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in th... Class I Baxter Healthcare Corp.
Dec 15, 2015 Asset extreme+PLUS Capsules, 500 mg, 30-count bottles, Distributed by Descor... Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 15, 2015 ZI XIU TANG BEAUTY FACE & FIGURE Capsules, 250 mg, 60-count bottles Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... Class I Bee Extremely Amazed LLC
Dec 11, 2015 FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bo... Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products... Class I Reesna, Inc
Dec 11, 2015 FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-c... Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products... Class I Reesna, Inc
Dec 9, 2015 Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bo... Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein a... Class I Lucy's Weight Loss (dba. Waisted With Lucy)
Dec 9, 2015 Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-... Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein a... Class I Lucy's Weight Loss (dba. Waisted With Lucy)
Dec 3, 2015 LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Produc... Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product ... Class I Lipo Escultura Corp.
Nov 23, 2015 SUPER HERBS 350 mg, 30 capsules per bottle. Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine ... Class I Super Herbs
Nov 6, 2015 Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol... Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecal... Class I Glades Drugs Inc.
Oct 28, 2015 Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled aut... Defective Delivery System; potential to have inaccurate dosage delivery Class I Sanofi-Aventis U.S. LLC
Oct 28, 2015 Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled au... Defective Delivery System; potential to have inaccurate dosage delivery Class I Sanofi-Aventis U.S. LLC
Oct 5, 2015 NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle... Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. Class I Inaffit, LLC
Oct 1, 2015 Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA. Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie... Class I MSNV, Inc dba National Video Supply
Oct 1, 2015 Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie... Class I MSNV, Inc dba National Video Supply
Sep 30, 2015 Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie... Class I Premiere Sales Group
Sep 30, 2015 Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie... Class I Premiere Sales Group
Sep 29, 2015 Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 o... Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be t... Class I Fit Firm and Fabulous
Sep 25, 2015 ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottl... Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets misla... Class I Medline Industries Inc
Sep 25, 2015 ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle,... Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets misla... Class I Medline Industries Inc
Sep 25, 2015 RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and da... Class I Tf Supplements

Frequently Asked Questions

When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.